MAUDE Adverse Event Report: ALERE SCARBOROUGH INC. ALERE DETERMINE HIV 1/2 AG/AB COMBO; IVD FOR HIV AG/AB

Catalog Number	7D2649
Medical Device Problem Code	False Positive Result (1227)
Health Effect - Clinical Codes	No Known Impact Or Consequence To Patient (2692); No Information (3190)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Testing was performed at alere (b)(4) on retained kit lot 160904 with the following internal whole blood and serum/plasma control samples: (b)(6), (b)(6), p24 (b)(6), and (b)(6).All test results were valid and performed as expected.Additionally, the manufacturing batch records for lot 160904 were reviewed.This lot met the required release specifications.A review of the complaints reported (b)(6) or unconfirmed (b)(6) related to lot number 160904 showed that the complaint rate is 0.041%.The evidence available does not indicate that the product is performing outside label claims.Additional investigation revealed that the customer was not following label instructions for performing the alere determine hiv ½ ag/ab combo test.There were issues identified in the sample collection and application and issues with the addition of the chase buffer which can be associated with false results (b)(6).The available evidence suggests that this device lot is performing within labeled claims.
Event or Problem Description
This report represents 1 of 7 (b)(6) alere determine hiv 1/2 ag/ab combo patient results (fingerstick whole blood) reported from a customer to an alere representative.(b)(6) were confirmed (b)(6) by a 4th generation (b)(6) test.There is insufficient information to determine if a malfunction occurred.The patient(s) gender, pregnancy status, treatment and patient outcome were unknown.The date(s) of occurrence are unknown.At the time of the event there was no indication of a product malfunction based on the information provided and assessed by alere (b)(4); however, this mdr is a retrospective filing in response to an observation from an fda inspection conducted february 26th to march 2nd , 2018 at alere (b)(4).

• Brand Name: ALERE DETERMINE HIV 1/2 AG/AB COMBO
• Common Device Name: IVD FOR HIV AG/AB
• Manufacturer (Section D): ALERE SCARBOROUGH INC.; 10 southgate road; scarborough ME 04074
• MDR Report Key: 7602311
• Report Number: 1221359-2018-00431
• Device Sequence Number: 1775038
• Product Code: MZF
• UDI-Device Identifier: 07290015003742
• UDI-Public: (01)07290015003742(17)180127(10)160904
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: BP120037-0
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/15/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/27/2018
• Device Catalogue Number: 7D2649
• Device Lot Number: 160904
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/30/2018
• Initial Report FDA Received Date: 06/14/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1